Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
1. The Amendment filed October 27, 2025 in response to the Office Action of July 25, 2025 is acknowledged and has been entered. Claims 2 and 12 have been cancelled. Claims 1, 3, 8 and 13 have been amended. Claims 5 and 14-24 were previously withdrawn as not being drawn to an elected species or invention.
2. Claims 1, 3, 4, 6-11 and 13 are currently being examined.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
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See CRFD of October 29, 2025.
Rejections Maintained
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim(s) 1, 3, 4, 6-11 and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0125919 A1 (Jooss et al Apr. 28, 2022, file Nov. 7, 2019), for the reasons of record set forth below.
Jooss teaches a method for stimulating an immune response in a subject, the method comprising administering to the subject a composition for delivery of an expression system and administering to the subject an inhibitor of Type I interferon signaling, wherein the composition for delivery of the expression system comprises the expression system, wherein the expression system comprises one or more vectors, the one or more vectors comprising: (a) an RNA alphavirus backbone, wherein the RNA alphavirus backbone comprises: (i) at least one promoter nucleotide sequence, and (ii) at least one polyadenylation (poly(A)) sequence; and (b) a cassette, wherein the cassette comprises: (i) at least one nucleic acid sequence, optionally wherein the at least one nucleic acid sequence comprises a polypeptide-encoding nucleic acid sequence, optionally wherein the polypeptide-encoding nucleic acid sequence is an antigen-encoding nucleic acid sequence comprising: a. an epitope-encoding nucleic acid sequence, optionally comprising at least one alteration that makes the encoded epitope sequence distinct from the corresponding peptide sequence encoded by a wild-type nucleic acid sequence, b. optionally a 5′ linker sequence, and c. optionally a 3′ linker sequence; (ii) optionally, a second promoter nucleotide sequence operably linked to the at least one nucleic acid sequence; and (iii) optionally, at least one second poly(A) sequence, wherein the second poly(A) sequence is a native poly(A) sequence or an exogenous poly(A) sequence to the alphavirus. See claim 1.
Jooss teaches that the inhibitor of Type I interferon signaling includes the antibodies MAR1-5A3 and Anifrolumab. See ¶¶ 0426-0428 and claims 25-29.
Jooss teaches that the antigens include viral antigens and influenza virus antigens. See ¶¶ 0268, 0490-0493, Table 37, and Figs. 2B and 5B.
Jooss teaches the components of the invention in pharmaceutical compositions in effective amounts. See ¶¶ 0009, 0075, 0078, 0079, 0344, 0345, 03500386-0389, 0404, and 0426 and claims 141, 146 and 0151-0158.
Jooss teaches administering a vaccine prior to, concurrently or subsequent to administration of the inhibitor of Type I interferon. See ¶¶ 0079, 0142 and 0271-0284 and 0428, and claims 150-157.
Jooss teaches the inhibitor of Type I interferon signaling can be administered 24 hours or less before administration of the composition for delivery of the expression system. See ¶¶ 0040, 0118, 0119, and 0428.
Jooss teaches the MAG-25mer of SEQ ID NO: 35. See ¶ 0614.
Jooss SEQ ID NO 35:
MAGMFQALSEGCTPYDINQMLNVLGDHQVSGLEQLESIINFEKLTEWTSSNVMPILSPLTKGILGFVFTLTVPSERGLSCISEADATTPESANLGEEILSQLYLWPRVTYHSPSYAYHQFERRAKYKRHFPGFGQSLLFGYPVYVFGDCVQGDWDAIRFRYCAPPGYALLRCNDTNYSALLAVGALEGPRNQDWLGVPRQLVTRMQAIQNAGLCTLVAMLEETIFWLQAFLMALTDSGPKTNIIVDSQYVMGISKPSFQEFVDWENVSPELNSTDQPFWQAGILARNLVPMVATVQGQNLKYQGQSLVISASIIVFNLLELEGDYRDDGNVWVHTPLSPRTLNAWVKAVEEKKGIPVHLELASMTNMELMSSIVHQQVRTYGPVFMCLGGLLTMVAGAVWLTVRVLELFRAAQLANDVVLQIMELCGAAFRQVCHTTVPWPNASLTPKWNNETTQPQIANCSVYDFFVWLHYYSVRDTLWPRVTYHMNKYAYHMLERRAKYKRGPGPGAKFVAAWTLKAAAGPGPGQYIKANSKFIGITELGPGPG.
Jooss teaches the MAG-25mer comprises viral epitopes from at least influenza (GILGFVFTL) and HTLV (LLFGYPVYV) , and EBV (NLVPMVATV). . See ¶ 0466 and 0491-0493 and Table 37.
Jooss teaches administrating the anti-IFN antibody MAR1-5A3 (aIFNAR) to mice 24 hours prior to immunization with the MAG-25mer encoded by the VEE-MAG25mer samRNA (SEQ ID NO:4). See ¶¶ 00597-0601.
Jooss teaches pretreatment with aIFNAR led to a 22% increase of antigen-specific CD8 T-cells by the VEE-MAG25mer samRNA vaccine. See ¶ 0602 and Table 33.
Jooss teaches administrating the anti-IFN antibody MAR1-5A3 (aIFNAR) to mice 24 hours prior to, at the same time, 6 hours after, 12 hours after, or 24 hours after administering the samRNA vaccine with the MAG-25mer encoded by the VEE-MAG25mer samRNA (SEQ ID NO:4). See ¶ 0607.
Jooss teaches as shown in FIG. 27A and Table 34A, administration of the anti-IFNAR MAb 24 hours before, at the same time, or 6 hours after administering the samRNA vaccine resulted in a significantly improved CD8 T cell antigen-specific immune response relative to administering a control antibody. See ¶ 0607, FIG. 27A and Table 34A.
Response to Arguments
4. Applicant argues:
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Applicant's arguments have been considered, but have not been found persuasive. Regarding co-administering, co-administering the IFN-I blocking agent and an agent encompasses administering the agents at different times. As previously set forth, Jooss teaches as shown in FIG. 27A and Table 34A, administration of the anti-IFNAR MAb 24 hours before, at the same time, or 6 hours after administering the VEE-MAG25mer samRNA vaccine.
Regarding wherein the antigen is a viral vaccine, the instant specification teaches that a viral vaccine is a vaccine to ameliorate or prevent a disease caused by a natural infection. See ¶ [0054] of the published application. This includes administering viral antigens as well as whole viruses. As previously set forth, Jooss teaches the MAG-25mer comprises viral epitopes from at least influenza (GILGFVFTL) and HTLV (LLFGYPVYV) , and EBV (NLVPMVATV), which is a viral vaccine against influenza, HTLV, and EBV. See ¶ 0466 and 0491-0493 and Table 37.
Regarding the newly added wherein clauses, it is noted that a wherein clause in a method claim is not patentably given weight when it simply expresses the intended result of a process step positively recited. See MPEP 2111.04.
Nevertheless, regarding the transient blocking of IFN-I activity, to the extent the wherein clause is limiting, Jooss teaches administrating the same anti-IFN antibody MAR1-5A3 (aIFNAR) as claimed and thus anti-IFN antibody MAR1-5A3 would only transiently block IFN-I activity because the antibody has the same structure as claimed and would have the same function. Additionally, most treatments with agents to block IFN-I activity, other than a knockout of an IFN-I gene, would be transient given that therapeutics only have a finite active time in vivo until they are metabolized, degraded and/or excreted.
Regarding the enhancement of the immune response and vaccine efficacy, to the extent the wherein clause is limiting, Jooss teaches, as previously set forth, pretreatment with MAR1-5A3 (aIFNAR) led to a 22% increase of antigen-specific CD8 T-cells by the VEE-MAG25mer samRNA vaccine, which comprises viral epitopes from at least influenza (GILGFVFTL) and HTLV (LLFGYPVYV) , and EBV (NLVPMVATV). See ¶ ¶ 0466, 0491-0493 0602 and Tables 33 and 37. Additionally, as previously set forth, Jooss teaches as shown in FIG. 27A and Table 34A, administration of the anti-IFNAR MAb 24 hours before, at the same time, or 6 hours after administering the VEE-MAG25mer samRNA vaccine resulted in a significantly improved CD8 T cell antigen-specific immune response relative to administering a control antibody. See ¶ 0607, FIG. 27A and Table 34A. Thus, Jooss teaches co-administering the VEE-MAG25mer samRNA vaccine and the MAR1-5A3 (aIFNAR), which enhanced the immune response and vaccine efficacy of the VEE-MAG25mer samRNA vaccine.
Regarding wherein the vaccine vaccinates against acute viral infection, vaccination usually involves vaccinating uninfected, healthy subjects as taught by Jooss. Thus, to the extent the wherein clause is limiting, given that Joss vaccinates the same population with the viral vaccine composition and anti-IFN-1 blocking agent as claimed, the claimed method is anticipated.
Thus, Applicant’s arguments are not found persuasive for the reasons previously set forth and above and the rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
2. Claim(s) 1, 3, 4, 6-11 and 13 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0125919 A1 (Jooss et al Apr. 28, 2022, file Nov. 7, 2019), for the reasons of record set forth below.
Jooss teaches as set forth above, but does not teach a working example using anifrolumab and the MAG-25mer vaccine, which comprises an influenza antigen.
It would have been prima facie obvious at the time the invention was filed given that the level of skill in the art was high to combine the teachings of Jooss and use the anifrolumab and the MAG-25mer vaccine in combination because Jooss teaches using anifrolumab or MAR1-5A3 as Type I interferon inhibitors and that the anti-IFN antibody MAR1-5A3 in combination with the MAG-25mer vaccine improved CD8 T cell antigen-specific immune responses. Thus, one would have been motivated to use anifrolumab or MAR1-5A3 as Type I interferon inhibitors with the MAG-25mer vaccine given the improved antigen-specific immune responses by inhibition of Type I interferons.
Response to Arguments
6. Applicant argues
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Applicant's arguments have been considered, but have not been found persuasive.
In regard to the predictability and reasonable expectation of success of making and using the claimed invention based on Joss, Joss teaches all of the elements of the claimed invention as set forth above. Also Jooss teaches co-administering the VEE-MAG25mer samRNA vaccine and the MAR1-5A3 (aIFNAR) antibody, which enhanced the immune response and vaccine efficacy of the VEE-MAG25mer samRNA vaccine. Thus, one of skill in the art could have predictably made and used the teachings of Joss to transiently blockade IFN-1 with the MAR1-5A3 antibody to enhance the immune response and efficiency of the VEE-MAG25mer vaccine with a reasonable expectation of success.
In regard to the Examples and the improved immune response and vaccine efficiency when co-administering the anti-IVHN-1 MAR1-5A3 antibody with viral vaccines, as set forth above, Jooss teaches improved immune response and vaccine efficiency when co-administering the anti-IVHN-1 MAR1-5A3 antibody with viral vaccines. Thus, the observed improvements with the claimed co-administration method would have been expected. Therefore the observed improvements are not sufficient to show the non-obviousness of the claimed method. Thus, the rejection is maintained for the reasons previously set forth and above.
Conclusion
7. All other objections and rejections recited in the Office Action of July 25, 2025 are withdrawn in view of Applicant’s amendments and arguments.
8. No claims allowed.
9. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Epps-Smith can be reached on 571-272-0757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Peter J Reddig/
Primary Examiner, Art Unit 1642